Dose indicators and dispensing canister-indicator assemblies

ABSTRACT

An annular dose indicator ( 50 ) for use with a dispenser comprising a dispensing canister ( 10 ) comprising a substantially cylindrical container ( 1 ) having a closed end ( 2 ) and an open end ( 3 ), said open end of the container being equipped with a dispensing means ( 4 ) that comprises an outlet member ( 5 ) movable between closed and discharge positions and an adaptor comprising a support block ( 21 ) having a socket ( 22 ) adapted to receive the outlet member, the container and support block being reciprocally movable relative to each other to cause the outlet member to move to its discharge position thereby dispensing a dose, said annular dose indicator ( 50 ) comprising an annular housing ( 60 ) having an interior surface ( 64 ) defining a substantially circumferential cavity; a counter-ring ( 80 ), said counter-ring located in the cavity and being arranged to be moveable relative to the housing by rotation about an axis parallel or substantially parallel to linear reciprocal movement of container and support block; a driving member ( 90 ) mounted on the interior surface of the housing, said driving member engaging the counter-ring and being arranged to be selectively engaged during reciprocal movement of container and support block as to drive an incremental, rotational movement of the counter-ring; wherein said indicator ( 50 ) is arranged to be circumferentially mountable about the dispensing-canister ( 10 ), such that the first edge ( 51 ) of the indicator faces towards the closed end of the container, the second edge ( 52 ) of the indicator faces towards the outlet of the dispensing canister, so that at least the outlet member of the canister will extend beyond the second edge of the indicator.

FIELD OF THE INVENTION

The present invention relates to annular mechanical dose indicators,particularly suitable for use with medicinal dispensers, moreparticularly metered dose inhalers. The present invention also relatesto dispensing canister-indicator assemblies, in particular suchassemblies including medicinal aerosol dispensing canisters, moreparticular pressurized metered dose dispensing canisters, as well asdispensers comprising such dispensing canister-indicator assemblies.

BACKGROUND OF THE INVENTION

Inhalation therapy is becoming an increasingly important method ofadministering medicaments to a patient. The medicament is generallyformulated with suitable propellant and if appropriate other componentsand charged into a container, e.g. an aerosol vial. The container istypically fitted by means of a ferrule with a dispensing means, such avalve, in particular a metered dose valve, comprising an elongate outletmember (e.g. a valve stem) movable between closed and dischargedpositions, to provide a dispensing canister. The dispensing canister istypically used in conjunction with an adaptor, typically having apatient port, for example a mouthpiece or a port adapted for nasal use.The adaptor comprises a support block having a socket adapted to receivethe outlet member of the dispensing means and an orifice having opencommunication with the socket and the patient port. The container andthe support block are reciprocally movable relative to each other toallow the outlet member to move to its discharge position during theoperation or firing of the device, thereby dispensing a dose.

With a conventional press-and-breathe device in which the patient firesthe device by depressing the container towards the support block of theadaptor, while inhaling, a rough indication of the amount of medicamentremaining in the vial can be obtained by shaking the whole unit. Withexperience, the user can distinguish the difference in ‘feel’ between avial that is substantially full and one that is substantially empty.However, this method is necessarily far from precise and is even lesssatisfactory with a breath-actuated inhaler in which, because of theadditional parts, the mass of the aerosol contents is a smallerproportion of the total unit weight. Thus, a difficulty arising from useof such known devices is that the patient cannot precisely determine theamount of medicament in the container at any given time. In extremecases, a patient, possibly in an emergency situation and requiring animmediate dose of medicament, may find that the container will notdispense a dose because its contents have already been exhausted.

Although a number of dose counters or indicators for metered dosemedicinal products have been proposed over the last decade, nopressurized metered dose inhaler with a built in dose counter has yetbeen marketed.

Proposed dose indicators include electrical and/or electronic dosecounters, see for example U.S. Pat. No. 5,622,163 and WO 92/17231. Suchcounters can be disadvantageous in that they are relatively expensive.Furthermore, such counters require the use of a power source, such as abattery. Accordingly the reliability of such counters is overshadowed bythe reliability of the power source itself. Here it is to be appreciatedthat some patients, e.g. asthma sufferers, often carry a device withthem for extended periods of time and may only use the device on anoccasional basis. If during this extended period the power source isexhausted or runs out, the patient would be again faced with uncertaintyabout the precise number of doses contained in the device.

A number of mechanical dose counters have also been proposed. Most ofthese counters comprise quite a number individual components and/orrequire significant modification of the inhaler device, in particularthe adaptor. This makes mass production and assembly often complicatedand/or tedious. A number of mechanical dose counters require additionalcounter-containing structures. For example, each of the documents, U.S.Pat. No. 5,421,482, U.S. Pat. No. 5,718,355, U.S. Pat. No. 5,817,007,U.S. Pat. No. 6,082,358, EP 0 254 391, EP 0 949 584, WO 95/34874 and WO99/57019, relate to dose counting devices, which are provided on theexterior of an existing inhaler as an add-on counter-component. Suchadd-on counters suffer a number of disadvantages, including increasedoverall dimensions of the device resulting in a reduced ease in handlingof the device.

GB 1,317,315, GB 1,290,484, GB 2,320,489, DE 298 14 647, U.S. Pat. No.5,349,945, U.S. Pat. No. 5,482,030, WO 92/09324 and WO 98/56444, forexample, relate to devices with dose counters located substantiallybeneath the container in a region near the outlet means of thedispensing means and near or around the support block of the adaptor.Such arrangements can be disadvantageous in that modification of theadaptor geometry, such as greater dimensions, in the critical regionwhere atomization takes place is generally required. Furthermore, suchcounters are often not applicable for breath-actuated devices, becausethis region usually contains the trigger mechanism for thebreath-actuated firing of the device.

WO 93/24167 for example proposes actuating means for triggeringbreath-actuated firing with an associated dose indicator as a type ofadd-on system at the end of the dispensing canister distant to theoutlet member, which disadvantageously increases the overall dimensionsof the device and correspondingly reduces general handleability of thedevice.

WO 00/59806 also relates to devices having an adaptor provided with adose-indicating means.

EP 0 414 536 discloses a breath-actuated inhaler having an indicatorwith a ring mechanism located in the adaptor and mounted for rotation.

Another problem is that many dose counters do not differentiate betweenthe same container being removed and put back in the adaptor (e.g. forcleaning) and a new container being inserted as a replacement, so thatthe count may or may not properly reset to the beginning.

SUMMARY OF THE INVENTION

Thus, there is an ongoing need for a simple, reliable, inexpensive,unobtrusive mechanical dose counter for use with a dispenser, such as amedicinal dispenser or more particularly a metered dose inhaler.

Moreover, there is a need for a mechanical dose counter for use with adispenser comprising a dispensing canister comprising a substantiallycylindrical container having a closed end and an open end, said open endof the container being equipped with a dispensing means that comprisesan outlet member movable between closed and discharge positions and anadaptor comprising a support block having a socket adapted to receivethe outlet member, the container and support block being reciprocallymovable relative to each other to cause the outlet member to move to itsdischarge position thereby dispensing a dose.

According to one aspect of the invention there is provided an annulardose indicator comprising

-   an annular housing having an interior surface defining a    substantially circumferential cavity;-   a counter-ring, said counter-ring located in the cavity and being    arranged to be moveable relative to the housing by rotation about an    axis parallel or substantially parallel to linear reciprocal    movement of container and support block;-   a driving member mounted on the interior surface of the housing,    said driving member engaging the counter-ring and being arranged to    be selectively engaged during reciprocal movement of container and    support block as to drive an incremental, rotational movement of the    counter-ring;-   wherein said indicator is arranged to be circumferentially mountable    about the dispensing-canister, such that the first edge of the    indicator faces towards the closed end of the container, the second    edge of the indicator faces towards the outlet of the dispensing    canister, so that at least the outlet member of the canister will    extend beyond the second edge of the indicator.

Typically, the two edges of the annular dose indicator are defined bythe two edges of the annular housing.

Suitably the driving member is engaged by the adaptor, in particular anelement thereof, during the reciprocal movement of the container andsupport block as to drive an incremental, rotational movement of thecounter-ring. The incremental rotation of the counter-ring is suitablyindicative of the successive dose firings.

The outer side of the counter-ring is preferably adjacent to theinterior surface of the housing. The outer side of the counter-ringadvantageously comprises indicia which are viewable through the housingto provide a visual indication of the total quantity of doses dispensedfrom, or remaining in, the container.

The indicator is preferably arranged such that the counter-ring islocatable about a portion of the container. Desirably the inner side ofthe counter-ring is adjacent to an exterior surface of the container.

More particularly, for use with dispensing canisters in which thecontainer is equipped with a dispensing means by means of a ferrule,said ferrule having a seal-edge (an external edge of the ferrule near towhere the open end of the container is sealed), the indicator ispreferably arranged such that the counter-ring is locatable about aportion of the container and/or a portion of the ferrule. Desirably, theinner side of the counter-ring is adjacent to an exterior surface of thecontainer and/or the ferrule. Preferably, the indicator is arranged,such that the second edge of the indicator is locatable near, morepreferably adjacent to, the seal-edge of the ferrule.

The dose indicator desirably includes at least one stop member providedon the interior surface of the housing and engaging the counter-ring toprevent substantial movement of counter-ring along said axis. In anotherpreferred embodiment the dose indicator further comprises at least onenon-return member provided on the interior surface of the housing, saidnon-return member engaging the counter-ring to permit incrementalrotation of the counter-ring in only one direction. The stop memberand/or the non-return member are desirably integral with the housing,more desirably form-molded elements on the interior surface of thehousing. Desirably, the stop member is integral with the non-returnmember, more desirably the stop member is simultaneously the non-returnmember.

Annular dose indicators according to the invention are advantageous inthat the indicator can be manufactured independent of thedispensing-canister and the adaptor to provide a self-containedassembly. They can be easily mounted around the dispensing canister bysliding the indicator over the outlet- or container-end of thedispensing canister, as the case may be. This simplifies the productionand handling of the indicator itself as well as the assembly of acomplete dispenser or a dispensing-canister/indicator assembly.Production is also simplified in that the dose indicators according tothe invention and in particular certain preferred embodiments thereofinclude a limited number of components. Because the counter-ring anddriving member are located or mounted within the housing of theindicator, the sensitive components of the indicator are protected,providing desirable robustness, ease in handling as well as resistanceto tampering during use.

In use, dose indicators according to the invention are locatedsubstantially about the dispensing-canister and above the outlet means,and thus the indicator can be advantageously used in bothpress-and-breathe inhalers and breath-actuated inhalers, in which thetriggering or breath actuation mechanism is located near or about thesupport of the adaptor. Also because the indicators are positioned aboutthe dispensing-canister, so that the first edge of indicator, whichfaces towards the closed end of the container, does not extend axiallybeyond the closed end of the container, a necessary increase in axialdimensions can be avoided, which is particularly advantageous in aportable inhaler.

Dose indicators according to the invention can be readily used withvarious types of dispensing canisters. Certain preferred embodiments ofthe dose indicator are particularly advantageous for use with dispensingcanisters having a container, whose diameter of its outermostcircumference is greater than the diameter of the outermostcircumference of the ferrule and/or a container having a constrictedportion, if applicable near or adjacent to the ferrule (distant to theoutlet member). Here the space formed by the recess in thedispensing-canister-profile can be advantageously used for thecomponents of the dose indicator, for example the counter-ring and thusthe overall dimensions of the counter-ring and/or indicator can be keptin relation to the dispensing-canister to aminimum. Containing the doseindicator within the profile of the dispensing canister may also have anadditional advantage of interfering less with the airflow through andwithin a dispenser or adaptor. In particular for use with suchcanisters, it is preferred that the diameter of the outermostcircumference of the counter-ring is less than the diameter of theoutermost circumference of the container.

It is preferred that the diameter of the outermost circumference of theindicator (typically the outermost circumference of the housing of theindicator) is less than, equal to or substantially equal to (i.e. ±up to0.5 mm, more preferably ±up to 0.03 mm) the diameter of the outermostcircumference of dispensing canister, in particular the container. Morepreferably the outermost circumference of the indicator, in particularthe housing, is equal to or substantially equal to the outermostcircumference of the dispensing canister.

Furthermore dose indicators, in particular the housing, can beadvantageously secured to an external surface of the dispensingcanister, preferably to an external surface of the container or, ifapplicable the ferrule of the dispensing canister, to provide aself-contained canister/indicator assembly.

The provision of a dispensing-canister/indicator assembly as aself-contained or single unit in which the indicator is locatedsubstantially about the dispensing canister (e.g. the container of thecanister and/or the canister closure means) and above the outlet meansof the canister is particularly advantageous, because such an assemblyis desirably robust. Furthermore such an assembly allows for desirableease in handling and assembly of a complete dispenser. In particular,the insertion of the outlet means into the support block of an adaptor,is desirably facilitated for large scale assembly and more importantly,if desired, by a patient, because the outlet means of thedispensing-canister is unobstructed by components of a dose counter.

Accordingly, in another aspect of the present invention there isprovided a canister-indicator assembly comprising

-   a dispensing canister comprising a substantially cylindrical    container having a closed end and an open end, said open end of the    container being equipped with a dispensing means that comprises an    outlet member movable between closed and discharge positions;-   and an annular mechanical dose indicator mounted circumferentially    about the dispensing-canister and secured to an external surface of    the dispensing canister, such that the first edge of the indicator    faces towards the closed end of the container and the second edge of    the indicator faces towards the outlet of the dispensing canister,    so that at least the outlet member of the canister extends beyond    the second edge of the indicator.

Preferably the indicator is secured to an external surface of thecontainer. In particular the indicator is desirably secured to theexternal surface of the container in the vicinity of the first edge ofthe indicator.

Preferred embodiments comprise a dispensing canister in which thecontainer is equipped with a dispensing means by means of a ferrule,said ferrule typically having a seal-edge near the open end of thecontainer. The indicator is preferably attached to an external surfaceof the ferrule or the container, more preferably the container.Preferably, the second edge of the indicator is located near, morepreferably adjacent to the seal-edge of the ferrule. Desirably, thediameter of its outermost circumference of the container is greater thanthe diameter of the outermost circumference of the ferrule.

Preferably the diameter of the outermost circumference of the indicatoris less than, equal to or substantially equal to (i.e. ±up to 0.5 mm,more preferably ±up to 0.3 mm) the diameter of the outermostcircumference of the dispensing canister, in particular the container.

Canister-indicator assemblies according to the invention areparticularly suitable for use with an adaptor comprising a support blockhaving a socket adapted to receive the outlet member, the container andsupport block being reciprocally movable relative to each other to causethe outlet member to move to its discharge position thereby dispensing adose from the container.

Desirably the annular mechanical dose indicator comprises an annularhousing having an interior surface defining a substantiallycircumferential cavity;

-   a counter-ring, said counter-ring located in the cavity and being    arranged to be moveable relative to the housing by rotation about an    axis parallel or substantially parallel to linear reciprocal    movement of container and support block; and-   a driving member mounted on the interior surface of the housing,    said driving member engaging the counter-ring and being arranged to    be selectively engaged during reciprocal movement of the container    and support block as to drive an incremental, rotational movement of    the counter-ring.

Another aspect of the present invention is a canister-indicator assemblyin kit of parts form comprising

-   a dispensing canister comprising a substantially cylindrical    container having a closed end and an open end, said open end of the    container being equipped with a dispensing means that comprises an    outlet member movable between closed and discharge positions; and-   an annular mechanical dose indicator arranged to be mounted    circumferentially about the dispensing-canister and secured to an    external surface of the dispensing canister, such that the first    edge of the indicator faces towards the closed end of the container    and the second edge of the indicator faces towards the outlet of the    dispensing canister, so that at least the outlet member of the    canister extends beyond the second edge of the indicator.

A further aspect of the present invention is an annular mechanical doseindicator for use with a dispensing canister comprising a substantiallycylindrical container having a closed end and an open end, said open endof the container being equipped with a dispensing means that comprisesan outlet member movable between closed and discharge positions, saidannular mechanical dose indicator being arranged to be mountedcircumferentially about the dispensing-canister and secured to anexternal surface of the dispensing canister, such that the first edge ofthe indicator faces towards the closed end of the container and thesecond edge of the indicator faces towards the outlet of the dispensingcanister, so that at least the outlet member of the canister extendsbeyond the second edge of the indicator.

In another aspect of the present invention, there is provided adispenser for dispensing doses of medicament comprising acanister-indicator assembly as described above and an adaptor comprisinga support block having a socket adapted to receive the outlet member ofthe dispensing-canister, the container and support block beingreciprocally movable relative to each other to cause the outlet memberto move to its discharge position thereby dispensing a dose from thecontainer.

Desirably the adaptor, in particular an element thereof, is arranged toselectively engage the dose indicator, in particular an element thereof,during reciprocal movement of the container and support block as todrive an incremental count of the number of doses dispensed from orremaining in the container.

The adaptor preferably comprises an elongate or generally cylindricalportion extending opposite the support block defining a chamber, inwhich the dose indicator and at least a portion of the container of thecanister-indicator assembly are locatable. Desirably thecanister-indicator assembly is reversibly removable from the adaptor. Inparticular, the end of the cylindrical portion distant to the supportblock is unobstructed and the canister-indicator assembly can bereversibly inserted and removed from the chamber of the adaptor. Theremay be situations in which it is desired to minimize access to the doseindicator, dispensing-canister or possibly other internal components ofa dispenser by the patient. In such cases, preferably the dose indicatorand at least a portion of, more particularly the entire container arelocated within said chamber and the canister-indicator assembly isirremovable from the adaptor or sealed within the adaptor.

Preferably the adaptor comprises a patient port, wherein the support hasan orifice having open communication with the socket and the patientport. The patient port may be detachable to allow washing and cleaningthereof. For those embodiments in which the adaptor includes an elongateor generally cylindrical portion, the detachable portion wouldpreferably include the support block to facilitate washing and cleaningof the support block and the orifice. For such embodiments, desirablythe dispensing canister-indicator assembly is non-removably locatedwithin the elongate or generally cylindrical portion of the adaptor.

The dispenser may be a non-pressurized metered dose pump spray dispenseror pressurized metered dose dispenser suitable for inhalation, nasal orsublingual administration of medicament. The dispenser is preferably apressurized metered dose inhaler, more particularly a press-and-breatheinhaler or a breath-actuated inhaler.

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a to c show isometric views of three exemplary dispensingcanisters suitable for use in the invention.

FIGS. 2 a and 2 b show vertical cross-sectional views of two exemplary,conventional adaptors; an adaptor for a press-and-breathe type inhalerand an adaptor for a breath-actuated inhaler.

FIG. 3 shows a vertical cross-sectional view of a breath-actuatedinhaler, i.e. the adaptor shown in FIG. 2 b, containing a dispensingcanister.

FIG. 4 shows an isometric view of a preferred embodiment of acanister-indicator assembly.

FIG. 5 shows an exploded view of a preferred embodiment of an annulardose indicator.

FIG. 6 shows an isometric view of the preferred annular dose indicatorillustrated in FIG. 5.

FIG. 7 shows a cross sectional view of the preferred annular doseindicator illustrated in FIGS. 5 and 6, mounted and attached to adispensing canister of the type depicted in FIG. 1 a, providing apreferred embodiment of a canister-indicator assembly.

FIGS. 8 a and b show vertical cross-sectional views of two preferredembodiments of a dispenser comprising a canister-indicator assemblyillustrated in FIG. 7.

FIGS. 9 a to d represent an enlarged, partial view of the preferreddispensers depicted in FIGS. 8 a and 8 b, showing the region of thedriving member of the dose indicator at various dispensing positions.

FIG. 10 shows a vertical cross-sectional view of a further preferredembodiment of a dispenser.

FIG. 11 shows a vertical cross-sectional view of another preferredembodiment of a dispenser.

FIGS. 12 a and b shows a vertical cross-sectional view of an additionalpreferred embodiment of a dispenser.

DETAILED DESCRIPTION OF INVENTION

It is to be understood that the present invention covers allcombinations of particular and preferred aspects of the inventiondescribed herein.

For a better understanding of the various aspects of the presentinvention, exemplary dispensing canisters suitable for use with thepresent invention as well as two exemplary conventional adaptors will beinitially described in the following.

In FIGS. 1 a to c three exemplary dispensing-canisters are illustrated.A dispensing canister (10) typically comprises a substantiallycylindrical container (1), in particular an aerosol container, having aclosed end (2), an open end (3, not visible) and a side-wall (9). Theopen end of the container is equipped with a dispensing means (4), inparticular, a dispensing valve, more particularly a metering dose valve,having an elongate outlet member (5), in particular a valve stem,movable between closed and discharged positions. The dispensing means isnormally mounted onto the container by means of a ferrule (6). Theferrule is typically fastened onto the container by crimping, however itcan be suitably fastened onto the container by other means, such aswelding, adhesives, snap-fit, thread-fit. The term ferrule is understoodhere to mean any component or element of the dispensing canister, whichis used to allow the attachment of the dispensing means to thecontainer. The ferrule may be an integral component of the dispensingmeans or alternatively be a separate component, e.g. in the form of amounting ring or cup. Alternatively the ferrule may be an integralcomponent of the container, e.g. an element or extension of thecontainer to allow the crimping or folding of the open end of thecontainer over an appropriate element of the dispensing means. Afterfastening (e.g. crimping), the ferrule typically shows a seal-edge (7)(e.g. a folded edge) near the open end of the container and often asecond edge (8) (e.g. a crimped edge) about the container (i.e. aboutthe side wall (9) of the container). The portion of thedispensing-canister located between the seal-edge (7) of the ferrule andthe elongate outlet member (5) is referred to as the nose (14) of thedispensing-canister. The height of the nose of the dispensing canistercan vary from being relatively flat (ratio of axial height of nose tocontainer <1:28), intermediate height (nose to container height ratiofrom 1:6 to 1:28) to being extended (nose to container heightratio >1:6). As can be seen in FIGS. 1 a to c, the diameter of theoutermost circumference of the ferrule may be less than, equal to orgreater than the diameter of the outermost circumference of thecontainer. The container (1) may have a constricted portion (11) distantto the closed end of the container (e.g. near or adjacent to ferrule) asdepicted in FIGS. 1 a and 1 b, and a corresponding non-constrictedportion (12) towards the closed end of the container; the boundary (13)between the constricted and non-constricted portions may be relevantlydistinct or relevantly continuous. It is to be understood that FIGS. 1 ato 1 c show three exemplary dispensing canisters, which are suitable foruse in the present invention, and that other dispensing canisters mayalso be suitable for use.

FIGS. 2 a and 2 b illustrate vertical cross-section views of twoexemplary adaptors (20). FIG. 2 a illustrates a conventional adaptorused for press-and-breathe type inhalers, while FIG. 2 b depicts aconventional adaptor including a breath-actuation or triggeringmechanism suitable for a breath-actuated inhaler. The adaptor comprisesa support block (21) having a socket (22). The outlet member (5) of thedispensing-canister (10) (e.g. the dispensing end of the elongate valvestem of a metered dose dispensing valve) is received by the socket (22)and thus positioned in the support block (21), e.g. as illustrated inFIG. 3 showing the adaptor of FIG. 2 b containing a dispensing-canister.The container (1) and the support block (21) are reciprocally movablerelative to each other along an axis, marked as “A” in FIG. 3. Theadaptor typically includes a patient port, such as a mouthpiece (23) andthe support has an orifice (24) having open communication with thesocket and the mouthpiece (23). The adaptor also typically includes anelongate or generally cylindrical portion (25) extending opposite thesupport block defining a chamber (26) to accommodate at least a portionof the container (1) of the dispensing-canister. One or more ribs (27)may be positioned within the chamber of the cylindrical portion to aidin locating and supporting the container in the correct position.

Referring to FIG. 3, the breath-actuation mechanism of the illustratedadaptor comprises a vane (31), which is pivotally mounted within themouthpiece (23), a rocker element (32) which supports a catch (33)pivotally mounted on the rocker at (34). When a patient inhales throughthe mouthpiece, inhalation causes pivotal movement of the vane. Thecurved surface (35) of the vane (31) and the curved surface (36) of thecatch (33) effectively acts as co-operating roller surfaces. Pivotalmovement of the vane (31) causes the curved surface (35) to rotate inone direction resulting in curved surface (36) of the catch rotating inthe opposite direction. This displacement of the catch moves from ablocking to an unblocking position allowing pivotal movement of therocker element (32) which in turns allows movement of the container (1)relative to the support block (21) under the influence of the cockingpressure (e.g. the patient pressing downwards on the container) causingthe valve to fire. The breath-actuation mechanism is described more indetail in EP 147 028, incorporated here by reference. Further examplesof breath or inhalation activatable dispensers are described in BritishPatent Specification Nos. 1,269,554, 1,335,378, 1,392,192 and 2,061,116and U.S. Pat. Nos. 3,456,644, 3,456,645, 3,456,646, 3,565,070,3,598,294, 3,814,297, 3,605,738, 3,732,864, 3,636,949, 3,789,843 and3,187,748 as well as WO 92/09323, WO 98/41254 and WO 01/70313 to 70317.

Referring to FIG. 4 showing an isometric view of a preferred embodimentof a canister-indicator assembly in accordance with the invention, theassembly (40) comprises a dispensing canister (10) and an annularmechanical dose indicator (50) having two edges (51,52). The indicator(50) is mounted circumferentially about the dispensing canister, suchthat the first edge (51) faces towards the closed end (2) of thecontainer and the second edge (52) faces towards the outlet of thedispensing canister, so that at least the outlet member (5) of thecanister extends beyond the second edge (52) of the indicator. Here, itis understood that the reference to the outlet member refers to theportion of the outlet member, which is located externally when thedispensing means is at rest (i.e. in its closed position). It ispreferred that the entire portion of the outlet member extends beyondthe second edge of the indicator.

Suitably, the container may be equipped with the dispensing means bymeans of a ferrule. The second edge (52) of the indicator is preferablylocated near, more preferably adjacent to, the seal-edge of the ferrule(not visible in FIG. 4).

As can be recognized in the preferred embodiment depicted in FIG. 4, theindicator (50) is secured directly to an external surface of thedispensing-canister (10), preferably an external surface of thecontainer (1) (in particular an external surface of the side-wall (9) ofthe container), more preferably an external surface of the container inthe vicinity of the first edge (51) of the indicator.

As shown in FIG. 4, the indicator may be secured by means anadhesive-coated film (55), which overlays an external surface (53) ofthe indicator, extending across the first edge (51) of the indicator,and the external surface of the side-wall of the container in thevicinity of said first edge. Alternatively, the indicator may be securedto an external surface of the ferrule. The indicator may be suitablysecured by other means including shrink sleeves, heat forming, crimpingand welding. Alternatively the indicator may be provided with a grippingmember for securing the indicator onto an external surface of thecontainer or the ferrule. To prevent tampering or detachment of theindicator, the indicator is preferably secured in a substantiallynon-reversible or substantially permanent manner. Preferred is theattachment of the indicator by adhesive or more preferably anadhesive-coated (in particular pressure-sensitive adhesive-coated) film.Suitable adhesives, in particular pressure-sensitive adhesives aretypically chosen so as to provide a high adhesive or permanent bond tothe particular substrate, e.g. indicator, container, ferrule, etc. Foradhesive-coated films, a suitable film thickness ranges from 0.05 mm to0.7 mm, more preferably 0.075 to 0.5 mm. The film may be made of anysuitable material, such as paper, plastic. Desirably, theadhesive-coated film is provided in the form of a label or tape; moredesirably a label or tape provided or printed with indicia concerningthe product contained in the dispensing canister and/or indicia to aidthe patient in reading an indication of the total quantity of dosesdispensed from or remaining in the container.

The diameter of the outermost circumference of the indicator ispreferably less than, equal to (e.g. as depicted in the preferredembodiment of FIG. 4) or substantially equal to the diameter of theoutermost circumference of the dispensing canister. More preferably thediameter of outermost circumference of the indicator is equal to orsubstantially equal to the diameter of the outermost circumference ofthe container.

The dispensing canister desirably comprises a container havingconstricted portion, in particular distant to the closed end of thecontainer and a non-constricted portion towards the closed end of thecontainer. The first edge of the indicator is desirably near or adjacentto the boundary between the constricted and non-constricted portion. Inpreferred embodiments comprising dispensing-canisters comprising aferrule, desirably the diameter of the outermost circumference of thecontainer is greater than the diameter of the outermost circumference ofthe ferrule

FIGS. 5 and 6 show an exploded diagram and an isometric view,respectively, of a preferred embodiment of an annular dose indicator inaccordance with the invention and an annular dose indicator suitable foruse in canister-indicator assemblies according to the invention. Asillustrated by the preferred embodiment shown in FIG. 5, the annulardose indicator (50) typically comprises three main components: anannular housing (60), a counter-ring (80) and a driving member (90).

The annular housing (60) has an interior surface (64) defining asubstantially circumferential cavity. Although the housing is preferablyin the form of a closed ring, as shown in FIG. 5, if desired the housingmay alternatively have an open ring form (e.g. ¾ or ⅞ ring). The firstand second edges (61, 62) of the annular housing are typicallysubstantially parallel to one another and are generally continuous aboutthe circumference of the housing. The housing may include one or morecut-out sections (65, 66) along the edges (61,62) for e.g. manufacturingand/or assembling purposes. The first and second edges (61, 62) of thehousing typically define the first and second edges (51,52) of theindicator. The external surface (63) of the housing typically definesthe external surface (53) of the indicator. The housing may include afolded lip or one or more radial protrusions (68) along the second edge(62).

The annular housing (60) may be made of any suitable rigid, durablematerial, such as metal, plastic or combinations of these materials.Plastic is preferred since it can be molded, preferably by highprecision molding, into a finished piece and thereby may be lessexpensive to manufacture. Preferably the housing comprises a transparentor translucent plastic. Suitable plastics include rigid, ductilepolymers having good impact strength, for example IZOD impact strengthgreater than or equal to 65 KJ/m², preferably greater than or equal to70 KJ/m² as determined by the method ISO 180-4β. For optimal molding,the polymer desirably exhibits good melt flow behavior, for example apolymer having a melt temperature around 280° C. would desirably exhibita melt volume-flow rate as determined by ISO 1133 at 300° C., 1.2 kgfrom 17 to 30 (preferably 17 to 22) cm³/10 min. Polycarbonates arepreferred. The housing is desirably provided with a window (67),optionally a magnifying window. The window may be formed as a cut-outportion of the housing, as a polished portion of the housing or asfitted window in the housing.

The internal surface (63) of the housing (60) may be provided with oneor more additional, preferably integral, more preferably form-moldedcomponents. For example, the internal surface is desirably provided witha bearing element (70) to facilitate the mounting of the driving member(90) on the interior surface of the housing. The internal surface of thehousing is desirably provided with an annular ridge (71) to help supportand position the counter ring (80). The annular ridge is typicallynon-continuous having two longitudinal edges (72,73) extending towardsthe second edge (62) of the housing. A limit member (74) may also bedesirably provided to facilitate movement of the driving member. Theinterior surface is preferably provided with at least one stop member(75). The preferred embodiment depicted in FIGS. 5 and 6 includes threestop members (75), one (visible) located towards the first edge (61)distant to the cut-out portion (66) and two (not visible) locatedbetween the two pairs of cut-out portions (65) along the first edge. Ascan be better seen in FIG. 6, the stop member engages the counter-ringin order to prevent substantial movement of the counter-ring along theaxis about which the counter-ring is moveable by rotation. The interiorsurface is also desirably provided with at least one non-retum member(76), typically in the form of one or more teeth, which engages thecounter-ring to permit incremental rotation of the counter-ring in onedirection. Preferably the non-retum member (76) is integral with thestop member (75), more preferably the stop member (75) is simultaneouslythe non-return member (76). The stop member and/or the non-return memberalso desirably facilitate the biasing of the counter-ring intoengagement with the driving member.

Thickness of housing, including components provided on the interiorsurface, typically ranges from 0.9 to 3 mm, preferably 1.1 to 2.5 mm,more preferably 1.2 to 1.7 mm, most preferably 1.4 to 1.6 mm. The wallthickness of the housing, i.e. excluding components provided on theinterior surface, typically ranges from 0.3 to 1.0 mm, preferably 0.4 to0.75 mm, more preferably about 0.4 to 0.6 mm, most preferably about 0.5mm.

The counter-ring (80) has an inner (84) and outer (83) side. Althoughthe counter-ring is preferably in the form of a closed ring, as shown inFIG. 5, if desired the counter-ring may alternatively have an open ringform (e.g. ¾ or ⅞ ring). As can be seen in FIG. 6, the counter-ring (80)is located in the cavity of the housing (60), preferably such that theouter side (83) of the counter-ring is adjacent to the interior surface(64) of the housing. The counter-ring (80) is arranged to be moveablerelative to the housing (60) by rotation about an axis parallel orsubstantially parallel to the linear reciprocal movement of thecontainer and support (e.g. axis depicted as “A” in FIG. 6). The outerside (83) of the counter-ring desirably comprises indicia (85), whichare viewable through the housing, to provide a visual indication of thetotal quantity of doses dispensed from, or remaining in, the containerof the dispensing-canister. The indicia may be suitably alphabetical,numerical, alphanumeric, or color symbols, providing a sequentialcount-up or count-down of dispensed doses or providing a more generalindication, such as “Full”, “Empty”, etc.

The counter-ring has two edges (81, 82), the first edge (81) towards thefirst edge (61) of the housing and the second edge (82) towards thesecond edge (62) of the housing and the driving member (90). As can besee in FIGS. 5 and 6, the counter-ring desirably has a set of teeth (86)along the second edge (82) of the counter-ring and one or more teeth ofthe set of teeth (86) are in engagement with the driving member. Thenumber of teeth in the set of teeth (86) is generally a function of thedispensing-canister in which the indicator is used with, in particularthe number of doses to be dispensed from the dispensing-canister.Generally the set of teeth includes an appropriate number of teeth toallow for the counting of up to 220 doses, more preferably up to 190doses, even more preferably up to 160 doses and most preferably up to130 doses. Desirably the set of teeth (86) along the second edgeincludes a spacer gap and/or a spacer block (87) to prevent more thanone full revolution of the counter-ring. In alternative embodiments inwhich the counter-ring is provided in the form of an open-ring, the gapin the open-ring would allow for the prevention of more than one fullrevolution. Desirably the counter-ring has a second set of teeth (88)along the first edge (81) of the counter-ring. One or more teeth of thesecond set of teeth (88) are preferably in engagement with the stopmember (75) and/or non-return (76) member. As will be appreciated bythose skilled in the art, the indicator may be arranged such that thenon-return member may alternatively be in engagement with one or moreteeth of the first set of teeth (86).

The counter-ring (60) may be made of any suitable rigid, durablematerial, such as metal, plastic or combinations of these materials.Again due to manufacture considerations and costs, plastic is preferred.Preferably the counter-ring comprises a printable polymer. Thecounter-ring is typically prepared by high precision molding. Preferablythe polymer exhibits good melt flow behavior, for example a polymerhaving a melt temperature around 220 to 225° C. would desirably exhibita melt volume-flow rate as determined by ISO 1133 at 250° C., 2.16 kgbetween 25 and 45 cm³/10 min, preferably 37 to 42 cm³/10 min.Polybutylene terephthalate (PBT) polymers are preferred.

The wall thickness of the counter-ring typically ranges from 0.4 to 2.0mm, preferably 0.7 to 1.5 mm, more preferably 0.90 to 1.3 mm, mostpreferably about 0.95 mm.

As depicted in FIG. 6, the driving member (90) is mounted on theinterior surface (64) of the housing. The driving member (90) engagesthe counter-ring (80), in particular the driving member desirablyincludes at least one pawl (93), preferably two or more pawls inengagement with teeth of the first set of teeth (86) of thecounter-ring. As described in more detail below, the driving member isarranged to be selectively engaged, in particular by the adaptor, moreparticularly an element thereof, during reciprocal movement of thecontainer and support block as to drive an incremental, rotationalmovement of the counter-ring. In particular, the driving member, asbetter seen in FIG. 5, preferably includes an V-shaped, spring portion(91), integral with a shallow U-shaped portion (92) including a pawl,preferably two pawls, (93) provided at the end of U-shaped portiondistant to the spring portion.

It should be appreciated that the driving member of the preferred doseindicator of FIGS. 5 and 6 represents one possible form of a suitabledriving member. Suitable driving members may be provided in a variety ofsuitable forms including one or more pawls for engagement with thecounter-ring.

The driving member (90) may be made of any suitable durable material,such as metal, plastic or combinations of these materials, preferablyplastic. For optimal molding, preferably high precision molding, thepolymer desirably exhibits good melt flow characteristics. Suitablepolymers includes polymers having a Young's modulus greater than orequal to 2500 MPa, preferably greater than or equal to 3000 MPa (asdetermined by ISO 527 parts I and II) and a tensile strain at breakgreater than or equal to 4%, preferably greater to or equal to 5.5% (asdetermined by ISO 527 parts I and II). Preferred are PBT,poly-oxymethylene (POM) and LCP polymers. Desirably the material of eachthe driving member, housing and counter-ring is selected, such that thefrictional behavior between the driving member and each the housing andcounter-ring is low, preferably a substrate-substrate frictioncoefficient less than or equal to 0.3.

The thickness of the driving member, typically having substantially thesame thickness as the counter-ring, generally ranges from 0.4 to 2.0 mm,preferably 0.7 to 1.5 mm, more preferably 0.90 to 1.3 mm, mostpreferably about 0.95 to 1.0 mm.

In assembly of the preferred indicator depicted in FIGS. 5 and 6, thedriving member is mounted on the bearing element (70) at the interface(94) of the spring and pawl-bearing portions (91, 92) of the drivingmember. The end (95) of the spring portion (91) is positioned against alongitudinal edge (72) of the ridge (71), while the pawl-bearing portion(92), is positioned adjacent to and substantially about the limit member(74). The counter-ring (80) is then inserted into cavity of the housing(60), by sliding the counter-ring over the stop member or members (75).The cut-out portions (65) along the first edge (61) of the housing (60)facilitate the insertion of the counter-ring (80) by deflectingoutwards. Once the counter-ring (80) is inserted beyond the stopmember(s) (75) into engagement with the driving member (90), the stopmember(s) prevent any substantially linear movement of the ring alongaxis “A”.

FIG. 7 shows a partial, cross-sectional view of a preferred embodimentof a canister-indicator assembly. In particular, FIG. 7 shows thepreferred dose indicator assembly as depicted in FIGS. 5 and 6 mountedand secured to a dispensing canister of the type depicted in FIG. 1 a.As can be recognized from FIG. 7, the annular dose indicator (50) ismounted onto the dispensing canister (10) by sliding it over thedispensing canister, in particular over the outlet-end of the dispensingcanister. The indicator, in particular the housing (60), is secured tothe external surface of the dispensing canister (10), in particular theside wall (9) of the container (1) in the vicinity of the first edge ofthe indicator and housing (51,61) desirably by means of anadhesive-coated film (55) in a similar manner as described above. Theindicator housing (60) is advantageously immovable in relation to thedispensing canister, enhancing overall robustness and handleability ofthe canister-indicator assembly. The first edge of the indicator andhousing (51,61) is desirably located near the boundary (13) between theconstricted and non-constricted portions of the container. The secondedge of the indicator and housing (52, 62) is desirably located adjacentto the seal-edge (7) of the ferrule (6). To facilitate positioning ofthe indicator adjacent to the seal-edge of the ferrule, the second edge(62) of the housing (60) may be desirably provided with one or moreradial protrusions (68). These protrusions advantageously facilitatepositioning by providing a reference to aid the control of the relativepositions of the indicator and an actuation pin so that manufacturedassemblies operate within a narrow range of a specified counteractuation travel between the container and the support block. As can beseen in FIG. 7, the counter-ring (80) is desirably located about aportion (in particular a constricted portion) of the container (1) and aportion of the ferrule (6). The inner side of the counter-ring isdesirably adjacent to an exterior surface of the container and ferrule.In alternative, preferred embodiments, the counter-ring may be locatedjust about a portion of the container. The driving member (90) of thepreferred embodiment depicted in FIG. 7 is located adjacent to anexterior surface of the ferrule (6).

In the embodiment illustrated in FIG. 7, both the nose (14) as well asthe outlet means (5) extend beyond the second edge of the indicator. Inalternative, preferred embodiments, the second edge of the indicator andhousing may be located about the dispensing canister on a level (orheight) near or adjacent to the level (or height) of the edge of thenose adjacent to the outlet means. The counter-ring may be desirablylocated about a portion of the ferrule or about a portion of the nose,the latter being particularly advantageous with dispensing canistershaving extended noses.

As illustrated in FIG. 7, advantageously, the diameter of the outermostcircumference of the indicator (50), in particular the housing (60), isequal to (or substantially equal to) the diameter of the outermostcircumference of the container. For embodiments in which thecounter-ring of the annular dose indicator is located about a portion ofthe container and/or the ferrule, the inner diameter of the counter-ringis typically greater than the diameter of the outermost circumference ofthe ferrule. For embodiments in which the counter-ring is located aboutthe nose, the inner diameter of the counter-ring may be less thediameter of the ferrule. However for such embodiments it is preferredthat inner diameter of the counter-ring is greater than the diameter ofthe outmost circumference of the ferrule. More particularly, for ease inmanufacturing the counter-ring, it is preferred that the outer diameterof the counter-ring be large as possible, while still providing anindicator and housing having an outermost circumference whose diameteris equal to or substantially equal to the diameter of the outermostcircumference of the container.

It is to be appreciated that the dimensions (e.g. outer and innerdiameter, height, etc.) of the dose indicator and its respectivecomponents will be selected in consideration of the dimensions ofparticular dispensing canister, on which the indicator will be mounted.In order to provide one example of the possible dimensions of a doseindicator, in the following reference will be made to a dispensingcanister and a dose indicator as illustrated in FIG. 7. For example, fora canister in which the diameter of the outermost circumference of thecontainer (1) is 24.5 mm and the diameter of the outermost circumferenceof the ferrule (6) is 21 mm, a suitable diameter of the innermostcircumference (excluding any radial protrusions (68)) of theindicator/housing (50,60) would be about 21.1 mm or greater, preferablyabout 21.1 to about 21.3 mm. A suitable diameter of the outermostcircumference of the indicator/housing (50,60) would be about 24.0 toabout 25 mm, preferably about 24.2 to 24.8 mm. For a canister in whichthe axial distance between the boundary (13) and the seal-edge (7) ofthe ferrule is 16.6 mm and the axial height of the constricted portionof the container is 10.6 mm, a suitable axial height of the housingwould be about 12 to about 14.8 mm, preferably about 14 to 14.4 mm,while a suitable height of the counter-ring would be about 4.5 to about4.9 mm.

It should be appreciated that although dose indicators according to theinvention are particularly advantageous for use withdispensing-canisters in which the diameter of the outermostcircumference of the ferrule is less than the diameter of the outermostcircumference of the container, the indicators may be also beadvantageous use with dispensing canisters in which the correspondingferrule diameter is equal to or greater than the diameter of theoutermost circumference of the container.

FIGS. 8 a and b show vertical cross-sectional views of two preferreddispensers (100), in particular a press-and-breathe inhaler and abreath-actuated inhaler, respectively, in accordance with the invention;each dispenser comprises an adaptor and a canister-indicator assembly ofFIG. 7.

The adaptor (20) comprises a support block (21) having a socket (22)adapted to receive the outlet member (5) of the dispensing-canister(10). The container (1) and the support block (21) are reciprocallymovable relative to each other along a linear axis, (marked as “A”) tocause the outlet member to move to its discharge position therebydispensing a dose from the container. The adaptor desirably includes apatient port, in particular a mouthpiece (23), and the support has anorifice (24) having open communication with the socket and themouthpiece (23). The adaptor desirably includes an elongate or generallycylindrical portion (25) extending opposite the support block defining achamber (26), in which the dose indicator (50) and at least a portion ofthe container (1) of the dispensing-canister are located or locatable.As can be appreciated from FIGS. 8 a and b, the canister-indicatorassembly is reversibly removable from the adaptor. In particular, theend of the elongate or generally cylindrical portion distant to thesupport block is unobstructed and the canister-indicator assembly can bereversibly inserted and removed from the chamber of the adaptor. Asillustrated in FIG. 8 b, the adaptor may desirably include abreath-actuation mechanism to provide a breath-actuated inhaler. (Thecomponents and the operation principle of the breath-actuation mechanismshown in FIG. 8 b are discussed above in conjunction with thebreath-actuated inhaler depicted in FIG. 3.)

In a comparison to the conventional press-and-breathe inhaler andbreath-actuated inhaler adaptors illustrated in FIGS. 2 a and 2 b, itcan be seen that the adaptors of the preferred dispensers shown in FIGS.8 a and 8 b reveal a minimum of structural change. The adaptor (20), inparticular the elongate or generally cylindrical portion (25) of theadaptor, is desirably provided with a window (28) to allow the user ofthe dispenser to read the indicia concerning the total quantity of dosesdispensed from, or remaining in, the container of thedispensing-canister. For ergonomic reasons, the window of the adaptor(28) is desirably positioned at the front side of the adaptor, i.e. theside of the adaptor in which the patient port is located or locatable.

Desirably the adaptor, in particular an element thereof, is arranged toselectively engage the dose indicator, in particular the driving member,during reciprocal movement of the container and support block as todrive an incremental count of the number of doses dispensed from orremaining in the container. More particularly, the adaptor isadvantageously provided with an actuation pin (29), typically as aform-molded element of the adaptor. In the embodiment shown in FIG. 8 a,the actuation pin (29) is provided as an extension of a rib (27). Whilein the embodiments shown in FIGS. 8 a and b, the actuation pin (29) isprovided as a molded element of the adaptor, other embodiments can beenvisaged in which the actuation pin (29) forms a part of the doseindicator itself.

When the outlet member (5) of the canister-indicator assembly (40) isinserted in the socket (22) of the support block (21), the actuation pin(29) is received within the dose indicator, e.g. passing through acut-out portion (66) in the second edge (62) of the housing (see FIG.5). During reciprocal linear movement (along axis “A”) of the containerand support block, the actuation pin (29), in particular the head of theactuation pin, selectively engages the driving member as to drive anincremental, rotational movement of the counter-ring. This is betterunderstood by reference to FIGS. 9 a to d, which show an enlarged viewof the dose indicator in the region of the driving member as well as theactuation pin at various dispensing positions: at the rest or closedposition; at a transitional position between the closed position and thefinal discharge position; at the final discharge position; and again atthe closed position.

As illustrated in FIG. 9 a, at the rest position, the head of theactuation pin (29) is located at a position adjacent an inclinedreceiving surface (96) of the pawl-bearing portion (92) of the drivingmember (90). The pawls (93) of the driving member are engaged with teethof the first set of teeth (86) of the counter-ring (80), while thenon-return member (76) in the form of two teeth (which is in thispreferred embodiment simultaneously the stop member (75)) are engagedwith teeth of the second set of teeth (88). As the container of thedispensing-canister moves towards the support block of the adaptor toallow the outlet member to move to its discharge position, the doseindicator moves towards the actuation pin (29), such that the head ofthe actuation pin moves, relative to the dose indicator, towards andengages the receiving surface (96) of the driving member (90) (see FIG.9 b). As the head of the actuation pin (29) moves along the receivingsurface (96), the driving member (90), in particular the pawl-bearingportion (92) thereof, is urged to slide in a direction substantiallyperpendicular to the movement the actuation pin. This movement of thedriving member in turn urges a rotational movement of the counter-ring(80). The limit member (73) desirably facilitates the sliding movementof the driving member in particular, to prevent over-movement of thedriving member and correspondingly an over-rotation of the counter-ring.The prevention of an over-rotation of the counter-ring is alsoadvantageously facilitated by the non-return member (76). As depicted inFIGS. 9 b and 9 c, during the rotation of the counter-ring, the teeth ofthe second set of teeth (88), with which the non-return member wasoriginally engaged, moves past the non-return member, so that thenon-return member moves into engagement with the next teeth at finaldischarge position. As can be seen, there is a squeezing action upon thecounter-ring between the actuation pin and the non-return member, thusthe angle of the inclined surface of each tooth of the non-return memberis desirably smaller with respect to the horizontal than the angle ofthe receiving surface of the driving member.

Upon return to the rest position (as the container of thedispensing-canister moves away from the support block), the doseindicator moves away from the actuation pin (29), such that the head ofthe actuation pin, in a relative movement, returns to its originalposition adjacent to the receiving surface (96) of the driving member(90) (see FIG. 9 d). The tension on the spring portion (91) of thedriving member (90) is released, allowing the driving member, inparticular pawl-bearing portion (92) thereto, to slide in the oppositedirection and thus moving the pawls (93) in engagement with next teethof the first set of teeth (86) of the counter-ring (80). During thismovement, the non-return member (76), which is in engagement with teethof the second set of teeth (88) of the counter-ring (80), desirably aidsin preventing rotational movement of the counter-ring.

FIG. 10 shows a vertical cross-sectional view of a further preferredembodiment of a dispenser, in particular a breath-actuated inhalerprovided with a cocking mechanism. This dispenser is similar to thedispenser shown in FIG. 8 b. The dispenser (100) further comprises ahousing (126) formed of a sleeve (127) and a crown (128), which can bemounted over the closed end of the container onto the adaptor (20), inparticular the elongate or generally cylindrical portion (25) thereof,e.g. by a threaded coupling (129). To prevent tampering of the indicator(50) and/or the breath-actuation triggering mechanism, the housing canbe desirably sealed or irreversibly coupled onto the adaptor, forexample by welding, adhesives or by means of a one-way snap fitconnection. In such embodiments, the dispensing canister-indicatorassembly can not be removed from the adaptor. The cocking mechanismcomprises a lever (130) which acts on a spring (131) facilitated by aspring guide (132). FIG. 10 shows the dispenser in the unprimedposition. Upon pivoting the lever, downward pressure is applied to theaerosol container providing the cocking force for the breath-actuationfiring of the dispenser. The dispenser may include a protective cover(133) for the mouthpiece (23).

FIG. 11 shows a vertical cross-sectional view of another preferredembodiment of a dispenser, in particular a press-and-breathe typeinhaler. The dispenser is similar to the dispenser shown in FIG. 8 a,but in this embodiment the dispenser (100) further comprises a cap(135), which is mounted, preferably irreversibly mounted, over theclosed end of the container onto the adaptor (20), in particular theelongate or generally cylindrical portion (25) thereof, such that atleast a portion of the cap is movable along axis “A” so that thedispenser-user can depress the dispensing canister (10), in particularthe container (1), towards the support block (21) to dispense a dose. Inthe embodiment shown in FIG. 11, the connecting end of the cappreferably comprises an annular edge turned outward (136) connected to acorresponding annular edge (137) (typically turned inward) of theadaptor, in particular the elongate or generally cylindrical portionthereof, so as to prevent the separation of the cap from the adaptor.(The type of coupling is generally understood as a one-way snap fitcoupling.) Thus, the canister-indicator assembly is non-removablylocated within the adaptor. The internal surface of the adaptor, inparticular the elongate or generally cylindrical portion, is desirablyprovided with a guide portion or depression (138), to allow axialtranslation of the cap. Thus, in use as the container and cap arepressed downwards towards the support block, the annular edge (136) ofthe cap moves downwards within the guide portion (138). For airflow,slits (139, not shown) may be provided in the cap and/or in the adaptorin the vicinity of the support block.

FIGS. 12 a and b show vertical cross-sectional views of an additionalpreferred embodiment of a dispenser, in particular a press-and-breathetype inhaler. The dispenser shown in FIG. 12 a comprises acanister-indicator assembly (40) of the type shown in FIG. 7 and anadaptor (20) comprising two parts: a support-portion (220) as well as anelongate or generally cylindrical portion or sleeve (225) defining achamber or cavity adapted to receive the dispensing canister-indicatorassembly (40). The support-portion (220), which comprises a patientport, in particular a mouthpiece (23) and a support block (21) having asocket (22) adapted to receive the outlet member of thedispensing-canister (10) and an orifice (24) having open communicationwith the socket and mouthpiece, is reversibly attachable and detachable.This can be best seen in FIG. 12 b showing the dispenser with thesupport-portion detached. As can be recognized from FIGS. 12 a and 12 b,the support-portion (220) is attached to and detached from the dispenserby inserting and removing the outlet member (5) into and out of thesocket block (21) of the support-portion. The support-portion istypically held securely in place due to the interference fit between theoutlet member (5) and the socket (22) of the socket block. To facilitatepositioning of the support-portion relative to the elongate or generallycylindrical portion, one or more positioning guides may be provided. Forexample, the support-portion (221) may include a guide slot (221)adapted to receive a guide pin (226) provided on the elongate orgenerally cylindrical portion (225) as the support-portion is attachedor reattached. Alternatively or in conjunction thereto, the elongate orgenerally cylindrical portion may be provided with a guide groove (227)adapted to receive a guide notch (222) provided on the socket block, asthe support portion is attached or reattached.

As shown in FIGS. 12 a and b, one or more extensions (228) are desirablyprovided on the internal surface of the chamber to aid in retaining thecanister-indicator assembly within the elongate or generally cylindricalportion as the support-portion is detached. During the detachment andreattachment of the support portion, the dispensing canister willtypically be fired dispensing a dose, which will be counted by theindicator. As shown in FIGS. 12 a and b, the dispenser preferablycomprises a cap (135) irreversibly mounted over the closed end of thecontainer onto the elongate or cylindrical portion (225), such that atleast a portion of the cap is movable along axis “A” so that thedispenser-user can depress the dispensing canister (10), in particularthe container (1), towards the support block (21) to dispense a dose.(The cap, elements thereof, etc. have been described above in connectionwith the dispenser embodiment shown in FIG. 11.) For airflow, slits(139) may be provided in the cap and/or in the adaptor in the vicinityof the support block. The dispensing canister-indicator assembly is thusadvantageously non-removably located within the elongate or cylindricalportion of the adaptor, and thus desirably protected from e.g.tampering, while the support-portion of the adaptor, including thepatient port and support block, is advantageously detachable from thedispenser for purposes of cleaning, etc.

Dispensers in accordance with the invention are suitable for dispensingmedicament, in particular medicinal aerosol products e.g. suitable foradministration to the lung by nasal or oral inhalation.

It will be understood that the present disclosure of particularpreferred embodiments in accordance with the invention is for thepurpose of illustration only and the invention extends to modifications,variations and improvements thereof.

1. An annular dose indicator for use with a dispenser comprising (a) adispensing canister comprising a substantially cylindrical containerhaving a closed end and an open end, said open end of the containerbeing equipped with a dispensing means that comprises an outlet membermovable between closed and discharge positions and (b) an adaptorcomprising a support block having a socket adapted to receive the outletmember, the container and support block being reciprocally movablerelative to each other to cause the outlet member to move to itsdischarge position thereby dispensing a dose from the container,comprising an annular housing having an interior surface defining asubstantially circumferential cavity; a counter-ring, said counter-ringlocated in the cavity and being arranged to be moveable relative to thehousing by rotation about an axis parallel or substantially parallel tolinear reciprocal movement of container and support block; a drivingmember mounted on the interior surface of the housing, said drivingmember engaging the counter-ring and being arranged to be selectivelyengaged during reciprocal movement of container and support block as todrive an incremental, rotational movement of the counter-ring; whereinsaid indicator is arranged to be slidably mountable about the dispensingcanister, such that the first edge of the indicator faces towards theclosed end of the container and the second edge of the indicator facestowards the outlet of the dispensing canister, so that at least theoutlet member of the dispensing canister will extend beyond the secondedge of the indicator.
 2. An annular dose indicator according to claim1, wherein the indicator is arranged such that the counter-ring islocatable about a portion of the container.
 3. An annular dose indicatoraccording to claim 1, wherein the outermost circumference of theindicator is less than, equal to or substantially equal to the diameterof the outermost circumference of the dispensing canister
 4. Adispensing canister-indicator assembly comprising a dispensing canistercomprising a substantially cylindrical container having a closed end andan open end, said open end of the container being equipped with adispenser that comprises an outlet member movable between closed anddischarge positions; and an annular mechanical dose indicator mountedcircumferentially about the dispensing canister and secured to anexternal surface of the dispensing canister, such that the first edge ofthe indicator faces towards the closed end of the container and thesecond edge of the indicator faces towards the outlet of the dispensingcanister, so that at least the outlet member of the canister extendsbeyond the second edge of the indicator.
 5. A canister-indicatorassembly according to claim 4, wherein the indicator is secured to anexternal surface of the container.
 6. A canister-indicator assemblyaccording to claim 5, wherein the indicator is secured to the externalsurface of the container in the vicinity of the first edge of theindicator.
 7. A canister-indicator assembly according to claim 4, incombination with an adaptor comprising a support block having a socketadapted to receive the outlet member, the container and support blockbeing reciprocally movable relative to each other to cause the outletmember to move to its discharge position thereby dispensing a dose fromthe container, wherein the indicator comprises an annular housing havingan interior surface defining a substantially cylindrical cavity; acounter-ring, said counter-ring located in the cavity and being arrangedto be moveable relative to the housing by rotation about an axisparallel or substantially parallel to linear reciprocal movement ofcontainer and support block; and a driving member mounted on theinterior surface of the housing, said driving member engaging thecounter-ring and being arranged to be selectively engaged duringreciprocal movement of container and support block as to drive anincremental, rotational movement of the counter-ring.
 8. Acanister-indicator assembly according to claim 7, wherein thecounter-ring is located about a portion of the container.
 9. Acanister-indicator assembly kit, comprising: a dispensing canistercomprising a substantially cylindrical container having a closed end andan open end, said open end of the container being equipped with adispenser that comprises an outlet member movable between closed anddischarge positions; and an annular mechanical dose indicator arrangedto be mounted circumferentially about the dispensing-canister andsecured to an external surface of the dispensing canister, such that thefirst edge of the indicator faces towards the closed end of thecontainer and the second edge of the indicator faces towards the outletof the dispensing canister, so that at least the outlet member of thecanister extends beyond the second edge of the indicator.
 10. Acanister-indicator assembly according to any one of claim 9, wherein thediameter of the outermost circumference of the indicator is less than orsubstantially equal to the diameter of the outermost circumference ofthe dispensing canister.
 11. An annular mechanical dose indicator foruse with a dispensing canister comprising a substantially cylindricalcontainer having a closed end and an open end, said open end of thecontainer being equipped with a dispensing means that comprises anoutlet member movable between closed and discharge positions, saidannular mechanical dose indicator being arranged to be mountedcircumferentially about the dispensing-canister and secured to anexternal surface of the dispensing canister, such that the first edge ofthe indicator faces towards the closed end of the container and thesecond edge of the indicator faces towards the outlet of the dispensingcanister, so that at least the outlet member of the canister extendsbeyond the second edge of the indicator.
 12. An annular mechanical doseindicator according to claim 11, wherein the diameter of the outermostcircumference of indicator is less than or substantially equal to thediameter of the outermost circumference of the dispensing canister. 13.A dispenser for dispensing doses of medicament comprising acanister-indicator assembly according to, claim 4, and an adaptorcomprising a support block having a socket adapted to receive the outletmember of the dispensing-canister, the container and support block beingreciprocally movable relative to each other to cause the outlet memberto move to its discharge position thereby dispensing a dose from thecontainer.
 14. A dispenser according to claim 13, wherein the adaptor isarranged to selectively engage the dose indicator during reciprocalmovement of the container and support block as to drive an incrementalcount of the number of doses dispensed from or remaining in thecontainer.
 15. A dispenser according to claim 13, wherein the adaptorfurther comprises an elongate or generally cylindrical portion extendingopposite the support block defining a chamber, the dose indicator and atleast a portion of the container of the canister-indicator assemblybeing locatable within said chamber.
 16. A dispenser according to claim15, wherein the canister-indicator assembly is reversibly removable fromthe adaptor.
 17. A dispenser according to claim 15, wherein the doseindicator and at least a portion of the container of thecanister-indicator assembly are located within said chamber and thecanister-indicator assembly is irremovable from the adaptor.
 18. Adispenser according to claim 13, wherein the adaptor further comprises apatient port and wherein the support has an orifice having opencommunication with the socket and the patient port.
 19. A dispenseraccording to claim 18, wherein the patient port is detachable from theadaptor.
 20. A dispenser according to claim 19, wherein a portion of theadaptor including the patient port and the support block is detachablefrom the adaptor.